An Evaluation of the Usability and Efficacy of a Prototype Handheld Urinal for Adults Who Suffer From Nocturia, Urge, Frequency, and/or Functional Incontinence
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in fluid intake
研究概览
简要总结
Usability and efficacy evaluation of a prototype handheld urinal for adult use
详细描述
28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suffers from nocturia urge, frequency, or funnctional incontinence
排除标准
- •Suffers only from stress UI
结局指标
主要结局
Changes in fluid intake
时间窗: 28 days
Quantitative analysis of levels of daily fluid intake i) when using the device and ii) not using the device.
Levels of user confidence
时间窗: 28 days
Qualitative self-assessments, on a three-point scale of "Not at all confident", "Reasonably confident" and "Very confident", by users of their confidence in their ability to manage urinary incontinence when using the device in a range of different orientations. Tool: questionairre
Change in level of user independence
时间窗: 28 days
Quantitative assessment of number of carer interventions required to assist users with urinary toileting when using and not using the device. Tool: user diary and questionairre
Change in incidence of falls associated with urinary toileting
时间窗: 28 days (3 months reported number of falls based on participant's recollection of incidence during that period)
Quantitative analysis of the number of falls incurred going to and from toilet while using the device over the 28 day study period compared to the number of falls recalled by participants going to and from the toilet during the 3 months prior to the study when not using the device. Tool: user diary and questionairre
Convenience in use
时间窗: 28 days
Qualitative self-assessment by users of the convenience in use of the device relative to other continence aids used on a three-point scale: "More convenient", "Neither more nor less convenient", and "Less convenient". Tool: questionairre
次要结局
未报告次要终点
